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違禁品（毒駕）檢測(cè)試劑條

LIMITATIONS OF THE TEST

The assay is designed for use with human urine only.
A positive result with any of the tests indicates only the presence of a drug/metabolite and does not indicate or measure intoxication.
There is a possibility that technical or procedural error as well other substances as factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce either positive results, or that do not interfere with test performance.
If a drug/metabolite is found present in the urine specimen, the assay does not indicate frequency of drug use or distinguish between drug of abuse and certain foods and medicines.
THC (GC/MS specifications are the value of 11-nor-D⁹-THC-9-COOH): In this study, one hundred twenty-two (122) negative and positive urine samples (0 to >2000 ng/ml) were tested and compared with GC/MS. The concentrations of three discrepant specimens were confirmed with GC/MS to be close to the cutoff value (48, 50 and 54 ng/ml). The results are summarized below:

Positive Agreement: 96.8 % and Negative Agreement: 98.3%

	(-)		(+)
Drug Screen	GC/MS Negative (0 ng/ml to 75%)	Near cutoff negative (75%- cutoff)	Near cutoff positive (cutoff to 125%)	GC/MS Positive (> 125%)	% Agreement with GC/MS
(+)	0	1	7	53	96.8 %
(-)	45	14	2	0	98.3 %
Total	45	15	9	53	97.5 %

Cocaine (GC/MS specifications are the value of benzoylecgonine): In this study, one hundred and ten (110) negative and positive urine samples (0 to 245682 ng/ml) were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cutoff value (284 and 328 ng/ml). The results are summarized below:

Positive Agreement: 98.2% and Negative Agreement: 98.1%

	(-)		(+)
Drug Screen	GC/MS Negative (0 ng/ml to 75%)	Near cutoff negative (75%- cutoff)	Near cutoff positive (cutoff to 125%)	GC/MS Positive (> 125%)	% Agreement with GC/MS
(+)	0	1	4	51	98.2 %
(-)	47	6	1	0	98.1 %
Total	47	7	5	51	98.2 %

PCP (GC/MS specifications are the value of phencyclidine): In this study, ninety-four (94) negative and GC/MS confirmed positive urine samples (0 to >1000 ng/ml) were tested and compared with GC/MS. The concentration of the discrepant specimen was confirmed with GC/MS to be close to the cutoff value (27.8 ng/ml). The results are summarized below:

Positive Agreement: 97.8% and Negative Agreement: 100%

	(-)		(+)
Drug Screen	GC/MS Negative (0 ng/ml to 75%)	Near cutoff negative (75%- cutoff)	Near cutoff positive (cutoff to 125%)	GC/MS Positive (> 125%)	% Agreement with GC/MS
(+)	0	0	5	40	97.8 %
(-)	46	2	1	0	100 %
Total	46	2	6	40	98.9 %

OPI 2000 (GC/MS specifications are the value of morphine or codeine): In this study, one hundred and five (105) negative and positive urine samples (0 to 50236 ng/ml) were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cutoff value (1836 and 2041.5 ng/ml). The results are summarized below:

Positive Agreement: 97.6% and Negative Agreement: 98.4%

	(-)		(+)
Drug Screen	GC/MS Negative (0 ng/ml to 75%)	Near cutoff negative (75%- cutoff)	Near cutoff positive (cutoff to 125%)	GC/MS Positive (> 125%)	% Agreement with GC/MS
(+)	0	1	7	33	97.6 %
(-)	56	7	1	0	98.4 %
Total	56	8	8	33	98.1 %